Once upon a time, Gilead was the purveyor of impossibly high-priced, but fantastically effective, hepatitis C drugs. Now attention has turned to its HIV pill, Truvada, which the CDC reportedly has some patents on. In a letter to the HHS, a cadre of US senators underscored their concern that the drug — which is approved to prevent HIV — could be infringing upon government patents and is being sold at a price that makes it unaffordable for many Americans.

Truvada — emtricitabine/tenofovir disoproxil fumarate — was approved in 2004 to treat HIV. In 2012, it was sanctioned by the FDA as a preventative treatment or PrEP (pre-exposure prophylaxis), in which individuals at high risk for HIV take medicines daily to lower their chances of contracting the infection. According to the CDC, daily PrEP reduces the risk of getting HIV via sexual intercourse by more than 90%.

According to a coalition of HIV/AIDs activists — the PrEP4All Collaboration — fewer than 10% of at-risk individuals in the United States receive Truvada as PrEP, and infection rates remain high (roughly 38,700 Americans became newly infected with HIV in 2016, according to US government estimates) particularly among people of color and men who have sex with men. The chief barrier is price: “Gilead charges $1600 per month for pills that cost as little as $6 per month abroad, meaning that some insurers do not cover it and individuals cannot afford to pay for it out of pocket,” according to an analysis by Yale Law School, which has partnered with PrEP4All.

In March, the Yale Global Health Justice Partnership published a report that found CDC scientists were the first to determine that the drugs that comprise Gilead’s Truvada could be used to prevent HIV transmission. As such, the agency was granted a patent in 2015 that covers HIV PrEP with a combination of emtricitabine and tenofovir disoproxil fumarate, the two drugs that make up Truvada. Two other patents were granted later. The Yale analysis concluded that Truvada appeared to infringe CDC’s patents for PrEP and that the US government could assert the patents and seek monetary damages.

“Gilead bore the risk and certainly the vast majority of the cost of research and clinical studies to demonstrate Truvada’s efficacy and safety as part of combination HIV therapy,” a Gilead spokesperson told Endpoints News.

“The HHS patents on the drug’s use for PrEP were filed more than a year after the drug had been discussed by scientists for PrEP, had been recommended and even prescribed off-label by physicians for prevention of HIV infections, and appeared in guidelines published by the CDC and other health care organizations for post-exposure prophylaxis (PEP) and PrEP. As such, the government did not invent PrEP, Truvada or Truvada for PrEP and its patents should not have been granted.”

Gilead generated global Truvada sales of nearly $3 billion last year, of which about $2.6 billion came from the United States. A generic version of Truvada is sold by Mylan $MYL in high-income European countries and Australia, and the CDC is collecting a “small” royalty on those sales, after the generic drugmaker unsuccessfully challenged the CDC patent in the European Patent Office, STATreported earlier this month.

In a letter posted earlier in April, the PrEP4All Collaboration highlighted that Gilead has “consistently increased the price of the drug, for both prevention and treatment, since its introduction” and that the CDC patents represent a potential “multi-billion dollar funding stream” via royalty payments that could fund a universal PrEP program to dramatically reduce the number of new HIV infections in the country and/or compell Gilead $GILD to dramatically lower the price of PrEP.

Gilead appears to potentially be marketing a prescription drug for uses that are patented by the US government, seven US Senators wrote in a letter published on Wednesday.

“We would like to know what steps have been taken to ensure that any usages by private companies of government-held patents are properly licensed and that any potential infringements are acted upon… Although Secretary Azar has stated that negotiations are ongoing, Gilead has reportedly reached no agreement with the government that would allow them to make use of these patented methods,” they wrote, seeking documents on the status of negotiations between the government and Gilead, among other requests.

“There are no ongoing negotiations between Gilead and HHS with respect to the patents owned by the government,” the company spokesperson said, adding that Gilead is in discussion with the government to determine the best way to broaden access to Truvada for PrEP.

Meanwhile, the US Department of Justice is reviewing the government PrEP patent, according to a report by the Washington Post, which cited a retired CDC scientist who was among agency staff speaking with a DoJ lawyer last week.

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